Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

October 3, 2016

Primary Completion Date

June 19, 2019

Study Completion Date

December 31, 2020

Conditions
Cushing's Disease
Interventions
DRUG

osilodrostat

In the form of filmcoated tablets for oral administration, in the following dose strengths: 1 mg, 5 mg, 10 mg, and 20 mg.

DRUG

osilodrostat Placebo

Matching Placebo in the form of filmcoated tablets for oral administration

Trial Locations (36)

3000

Novartis Investigative Site, Leuven

6000

Novartis Investigative Site, Lucerne

10032

Columbia University Medical Center New York Presbyterian Neuroendocrine Unit, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10330

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

15006

Novartis Investigative Site, A Coruña

19104

University of Pennsylvania Medical Center University of Pennsylvania, Philadelphia

28009

Novartis Investigative Site, Madrid

29009

Novartis Investigative Site, Málaga

34890

Novartis Investigative Site, Istanbul

41013

Novartis Investigative Site, Seville

41380

Novartis Investigative Site, Kocaeli

46026

Novartis Investigative Site, Valencia

46600

Novartis Investigative Site, Alzira

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

80045

University of Colorado Endocrinology Clinical Trials Unit, Aurora

97239

Oregon Health and Science University SC LCI699C2301, Portland

100034

Novartis Investigative Site, Beijing

100730

Novartis Investigative Site, Beijing

117036

Novartis Investigative Site, Moscow

510080

Novartis Investigative Site, Guangzhou

610041

Novartis Investigative Site, Chengdu

60430-275

Novartis Investigative Site, Fortaleza

21941-590

Novartis Investigative Site, Rio de Janeiro

04039 004

Novartis Investigative Site, São Paulo

05403 000

Novartis Investigative Site, São Paulo

B3H 1V7

Novartis Investigative Site, Halifax

H2W 1T8

Novartis Investigative Site, Montreal

J1H 5N4

Novartis Investigative Site, Sherbrooke

1406 1200

Novartis Investigative Site, San Pedro

106 76

Novartis Investigative Site, Athens

04-305

Novartis Investigative Site, Warsaw

31-501

Novartis Investigative Site, Krakow

03 242

Novartis Investigative Site, Warsaw

4200-319

Novartis Investigative Site, Porto

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY